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TOPILEX 100 mg. 30 tablets

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WHAT MAY BE TOPILEX AND WHAT IS IT USED FOR?
TOPILEX is a medicinal product for the treatment of epilepsy.
TOPILEX is used to treat epilepsy in patients whose seizures begin in a restricted part of the brain and / or generalized tonic clinical seizures.

It can be used alone or in addition to treatment with other antiepileptic medicinal products.
Topiplex is also used to prevent frequent migraine headache attacks in adults in cases where there is no effect of previous treatment with other medicinal products.

BEFORE YOU TAKE TOPILEX
Do not use Topilex:
- if you are allergic to topiramate or any of the other ingredients of Topilex
- for migraine prevention if you are pregnant or you are a woman of childbearing age and you are not using an effective contraceptive method.

Take special care with TOPILEX
- if you have kidney or liver disease. Contact your doctor for advice before starting treatment
- when staying in a warm temperature environment, perform physical exercise or physical work. In this case, take enough fluid to reduce the effect of side effects associated with high ambient temperatures. This is especially true for children, as it may reduce sweating during treatment with topiramate.
- if you have a kidney stone in the past. In this case, take more fluids. You should avoid taking medicines that can cause kidney stones or fatty foods that are poor in carbohydrates, as this may increase the risk of kidney stones.
- In case you suddenly see myopia and / or eye pain you should contact your doctor immediately. In a number of patients, this medicinal product may cause a sudden onset of glaucoma.
- if you notice any mood swings, feel depressed or have thoughts of being self-infected, you should immediately contact your doctor
- if you are using the medicine to prevent migraine attacks, check your weight. If you notice significant and persistent weight loss, please tell your doctor. Discontinuation of treatment may be necessary.
This medicinal product may reduce bicarbonate levels in your blood and cause excessive acidity of the blood. This is particularly true if you suffer from other diseases that make you sensitive to low levels of bicarbonates, dietary fat and protein diets, or other medicines. Typically, bicarbonate concentrations decrease at the start of treatment. Your doctor may ask you to take a blood sample to track the bicarbonate concentration in the blood.
There is only limited information on the use of this medicine in children under 12 years of age.
Few people treated with anti-epileptics such as toparamate had thoughts of self-harm or suicide. If these occur, immediately contact your doctor.

PREGNANCY BREAST
Contact your physician for advice before taking any medicinal product.
This medicinal product may harm your unborn child but, on the other hand, untreated epilepsy and severe seizures due to abrupt discontinuation of the medicinal product may result in more harm.
Your doctor will decide whether to continue, change or stop taking.
Your doctor may advise you to stop breast-feeding because topiramate is excreted in your breast milk.

Important information about some of  TOPILEX ingredients
TOPILEX contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before starting treatment.
Topilex contains sunset yellow color, which can cause allergic reactions.
HOW TO TAKE TOPILEX
The doctor prescribes the dose that is specific to you. Generally, treatment is started at a low dose, which is gradually increased to reduce the risk of side effects.
If you suffer from kidney or liver disease, your doctor may prescribe a lower dose and, for a longer time, adjust the dose.
Other dosages of the medicinal product are also available if the required dosage can not be reached with this medicinal product.

Self-treatment of epilepsy with Topilex

Adults and adolescents over 12 years of age

treatment is usually started at a dose of 25 mg, taken once in the evening for 1 week. The total daily dose is then increased every week or every two weeks with 25 or 50 mg daily. if you notice the occurrence of side effects, your doctor may increase the dose at a slower rate than usual or above the above mentioned intervals. The usual maintenance dose is 100 mg daily divided into two intakes. When used alone for the treatment of epilepsy, the maximum daily dose is 400 mg.

Use in combination with other antiepileptic medicinal products
Adults and adolescents over 12 years of age
Treatment usually starts with a dose of 25-50 mg taken every night for 1 week. The total daily dose is then increased every week or every two weeks with 25 or 50 mg daily. The usual daily dose is 200 - 400 mg divided into two intakes. In some patients, it is possible to achieve a good single-dose status. Some patients may need the maximum daily dose of 800 mg, which is a maximum dose and should not be exceeded.
When switching from treatment with different antiepileptic medicinal products to Topilex alone, a gradual dose reduction of other antiepileptic drugs is recommended by one third per week. In some cases, based on the medical advice, it is also possible to reduce the Topilex dose.
Prophylaxis of migraine in adults
Your doctor will start treatment with a 25 mg dose taken in the evening and then increase it to the lowest level necessary to prevent recurrence of migraine attacks. The usual maintenance dose is 50 mg taken twice daily but your doctor may advise you to take a lower dose.
Consult your doctor or pharmacist if you feel that Topiolex is too strong or too weak.

Mode of application
The active substance topiramate has a bitter taste. For this reason, tablets should not be split or crushed.
Take the tablets, regardless of food intake, with enough fluids.
POSSIBLE SIDE EFFECTS

Very common - fatigue, dizziness, drowsiness and nervousness, headache, nausea, weight loss, memory difficulties, loss of appetite, confusion, slow thinking, depression, concentration difficulties, anxiety, coordination issues, double vision, , speech disorders

Common - Anemia, nosebleed, red or violet spots on the skin, decreased white blood cells or platelets, feeling indifferent, frustration, euphoria, agitation, worrying thoughts, decreased sexual interest, aggressive reactions, constipation, abdominal pain, menstrual disorders, impotence, body and bone pain, insomnia.

Uncommon - hallucinations, personality disorders, suicidal thoughts, slow movements, slow thinking and feelings, shortness of breath, diarrhea, vomiting and dry mouth, itching, inflammation of the hair follicles.

Rare: elevation of liver enzymes, acute myopia due to glaucoma, eye pain, decreased neutrophil count.

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